GENTICOL 0.3% Krople do oczu, roztwór

Treść ulotki

1. Genticol 3 mg/ml eye drops, solution
   1. What is Genticol and what is it used for
   2. What you need to know before using Genticol
2. Genticol contains phosphate buffer (as disodium phosphate dodecahydrate,
   1. How to use Genticol
   2. Possible side effects
   3. How to store Genticol
   4. Contents of the pack and other information
3. Genticol 3 mg/ml eye drops, solution
   1. What is Genticol and what is it used for
   2. What you need to know before using Genticol
   3. How to use Genticol
   4. Possible side effects
   5. How to store Genticol
   6. Contents of the pack and other information
4. Genticol eye drops, solution appears as a clear solution inside
5. Genticol 3 mg/g ophthalmic ointment
   1. What is Genticol and what is it used for
   2. What you need to know before using Genticol
   3. How to use Genticol
   4. Possible side effects
   5. How to store Genticol
   6. Package Contents and Other Information

Genticol 3 mg/ml eye drops, solution

gentamicina

Read this leaflet carefully before you start using this medicine as it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Genticol is and what it is used for
• 2. What you need to know before you use Genticol
• 3. How to use Genticol
• 4. Possible side effects
• 5. How to store Genticol
• 6. Contents of the pack and other information

1. What is Genticol and what is it used for

Genticol contains the active ingredient gentamicin, which belongs to a group of
medicines called antibiotics (used for the treatment of bacterial infections). Genticol is used to treat external infections of the eye and adnexa, such as conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers,
blepharitis, blepharoconjunctivitis, dacryocystitis. It is also indicated in pre- and
post-surgical prophylaxis.
Consult your doctor if you do not notice an improvement or if you notice a worsening at the end of the prescribed therapy.

2. What you need to know before using Genticol

Do not use Genticol

• if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Genticol.
Prolonged use of topical antibiotics can lead to the growth of microorganisms
that are not sensitive to them.
Stop treatment if you experience signs of
sensitization to the components of the medicine and consult your doctor to
start appropriate therapy.

Children and adolescents
In children under 3 years of age, the product should be administered only when
absolutely necessary and under direct medical supervision.

Other medicines and Genticol
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
In particular, tell your doctor or pharmacist if you are taking:

• any other antibiotic, such as polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. The use of other antibiotics at the same time as Genticol may increase the risk of kidney problems, hearing problems or effects on the activity of antibiotics given in combination with Genticol;
• cisplatin, an anticancer drug;
• medicines that reduce fluid retention (diuretics), such as ethacrinic acid and furosemide.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before
using this medicine.
Pregnancy
During pregnancy, the product should be administered only when absolutely necessary and under
direct medical supervision.

Driving and operating machinery
There are no contraindications.

Genticol contains benzalkonium chloride
This medicine contains 6 micrograms of benzalkonium chloride per drop
equivalent to 0.2 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and may
cause a change in their color. Remove your contact lenses before using
this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride can also cause eye irritation, especially if you have
dry eyes or corneal disorders (the transparent superficial layer
of the eye). If you experience any abnormal sensation in your eye, burning or pain
after using this medicine, talk to your doctor.

Genticol contains phosphate buffer (as disodium phosphate dodecahydrate,

monosodium phosphate monohydrate)
This medicine contains 0.1911 mg of phosphate buffer per drop
equivalent to 6.37 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause, in very rare cases, opaque spots on the cornea due to
calcium accumulation during treatment.
The product must be used with caution in patients with a compromised cornea.
and in cases where the patient uses other ophthalmic products containing phosphates
(see section 4).
Patients without pre-existing corneal damage do not appear to be at risk.

3. How to use Genticol

Use this medicine following the instructions of your doctor exactly.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 – 2 drops of eye drops 3 - 4 times a day or as
prescribed by your doctor.
In the case of particularly resistant infections, the doctor will assess whether to increase
the frequency of administration up to six - eight times a day.

Instructions for use

• 1) Wash/sanitize your hands thoroughly.
• 2) Screw the cap on tightly to pierce the bottle.

• 3) Unscrew the cap, turn the bottle upside down and instill it by exerting a slight pressure on it, taking care not to touch the tip of the bottle with the eye, eyelid or any other surface; this can avoid contamination.

• 4) Close the bottle by screwing the cap on tightly.

If you use more Genticol than you should
No cases of overdose have ever been reported with the use of Genticol.

If you forget to use Genticol
Do not use a double dose to make up for a missed dose.

If you stop using Genticol
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects
although not everybody gets them.
Genticol may cause mild and temporary eye irritation.
If you have severe damage to the outermost transparent layer of the eye (the cornea), the
phosphates may, in very rare cases, cause opaque spots on the cornea due to
calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Genticol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the
packaging and on the vial after “Exp.”.
The expiry date refers to the last day of that month and to the product
intact, correctly stored.
This medicine does not require any particular storage conditions.
Genticol must not be used after 28 days from first opening.
Do not dispose of any medicine in the drain or in household waste. Ask your
pharmacist how to eliminate medicines that you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Genticol contains

• The active ingredient is gentamicin; 1 ml of solution contains 3 mg of gentamicin (as gentamicin sulfate).
• The other ingredients are: disodium phosphate dodecahydrate, monosodium phosphate monohydrate, sodium chloride, benzalkonium chloride, purified water.

Description of the appearance of Genticol and contents of the pack
Genticol eye drops, solution is presented as a clear solution in a bottle
containing 10 ml of eye drops.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano

Manufacturer
S.I.F.I. S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT)

Genticol 3 mg/ml eye drops, solution

gentamicina

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Genticol is and what it is used for
• 2. What you need to know before using Genticol
• 3. How to use Genticol
• 4. Possible side effects
• 5. How to store Genticol
• 6. Contents of the pack and other information

1. What is Genticol and what is it used for

Genticol contains the active substance gentamicin, which belongs to a group of
medicines called antibiotics (used for the treatment of bacterial infections).
Genticol is used to treat external infections of the eye and its appendages, such as
conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis,
blepharoconjunctivitis, dacryocystitis. It is also indicated in pre- and post-
surgical prophylaxis.
Consult your doctor if you do not notice an improvement at the end of the prescribed
therapy or if you notice a worsening.

2. What you need to know before using Genticol

Do not use Genticol

• if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Genticol.
Prolonged use of topical antibiotics can lead to the growth of microorganisms
that are not sensitive to them.
Stop treatment if you experience signs of
sensitization to the components of the medicine and consult your doctor to
start appropriate therapy.

Children and adolescents
In children under 3 years of age, the product should be administered only when
absolutely necessary and under direct medical supervision.

Other medicines and Genticol
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
In particular, tell your doctor or pharmacist if you are taking:

• any other antibiotic, such as polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. The use of other antibiotics at the same time as Genticol may increase the risk of kidney problems, hearing problems or effects on the activity of antibiotics administered in association with Genticol;
• cisplatin, an anticancer medicine;
• medicines that reduce fluid retention (diuretics), such as ethacrinic acid and furosemide;

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become
pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before
using this medicine.
Pregnancy
During pregnancy, the product should be administered only when absolutely necessary and under
direct medical supervision.

Driving and operating machinery
There are no contraindications.

Genticol contains phosphate buffer(as disodium phosphate dodecahydrate,
monosodium phosphate monohydrate)
This medicine contains 0.1911 mg of phosphate buffer per drop
equivalent to 6.37 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may cause, in very rare cases, opaque spots on the cornea due to
calcium accumulation during treatment.
The product should be used with caution in patients with a compromised cornea.
and in cases where the patient uses other ophthalmic products containing phosphates
(see section 4).
Patients without pre-existing corneal damage do not appear to be at risk.

3. How to use Genticol

Use this medicine following the instructions of your doctor exactly.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 – 2 drops of eye drops 3 - 4 times a day or according to
medical prescription.
In the case of particularly resistant infections, the doctor will assess whether to increase
the frequency of administration up to six - eight times a day.

Instructions for use

• 1) Wash/sanitize your hands thoroughly.
• 2) Make sure the single dose is intact.
• 3) Detach the single dose from the strip.

• 4) Open by twisting the top without pulling.

• 5) Instill the eye drops, taking care not to touch the tip of the single dose with the eye, with the eyelid or any other surface; this way contamination can be avoided.

The solution eye drops in single dose containers should only be used
immediately after opening. Any residue should not be
reused.

If you use more Genticol than you should
No cases of overdose have ever been reported with the use of Genticol.

If you forget to use Genticol
Do not use a double dose to make up for a missed dose.

If you stop using Genticol
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects
although not everybody gets them.
Genticol may cause mild and temporary eye irritation.
If you have severe damage to the outermost transparent layer of the eye (the cornea), the
phosphates may, in very rare cases, cause opaque spots on the cornea due to
calcium accumulation during treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Genticol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package
and on the label after “Exp.”.
The expiry date refers to the last day of that month and the product
intact, correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in the wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Genticol contains

• The active ingredient is gentamicin; 1 ml of solution contains 3 mg of gentamicin (as gentamicin sulfate).
• The other ingredients are: disodium phosphate dodecahydrate, sodium phosphate monobasic monohydrate, sodium chloride, purified water.

Description of the appearance of Genticol and contents of the pack

Genticol eye drops, solution appears as a clear solution inside

single-dose containers of 0.3 ml of eye drops.
Each pack contains 6 aluminum pouches. Each pouch contains a
strip of 5 single-dose plastic containers (LDPE).
Pack of 30 single-dose containers.

Marketing authorisation holder and manufacturer:
Marketing authorisation holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano

Manufacturer
S.I.F.I. S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT)

Genticol 3 mg/g ophthalmic ointment

Gentamicin

Read this leaflet carefully before you use this medicine because
it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 7. What Genticol is and what it is used for
• 8. What you need to know before you use Genticol
• 9. How to use Genticol
• 10. Possible side effects
• 11. How to store Genticol
• 12. Contents of the pack and other information

7. What is Genticol and what is it used for

Genticol contains the active ingredient gentamicin which belongs to a group of
medicines called antibiotics (used for the treatment of bacterial infections).
Genticol is used to treat external infections of the eye and its appendages, such as
conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis,
blepharoconjunctivitis, dacryocystitis. It is also indicated in pre- and post-
surgical prophylaxis.
Consult your doctor if you do not notice an improvement at the end of the therapy that has been prescribed to you or if you notice a worsening.

8. What you need to know before using Genticol

Do not use Genticol

• if you are allergic to gentamicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Genticol.
Prolonged use of topical antibiotics can lead to the growth of microorganisms
that are not sensitive to them.
Stop treatment if you experience signs of
sensitization to the components of the medicine and consult your doctor to
start appropriate therapy.

Children and adolescents
In children under 3 years of age, Genticol should be administered only in cases of actual
need under the direct supervision of a doctor.

Other medicines and Genticol
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines.
In particular, tell your doctor or pharmacist if you are taking:

• any other antibiotic, such as polymyxin B, colistin, viomycin, streptomycin, vancomycin and cefaloridine. Using other antibiotics at the same time as Genticol may increase the risk of kidney problems, hearing problems or effects on the activity of the antibiotics given in association with Genticol;
• cisplatin, an anticancer drug;
• medicines that reduce fluid retention (diuretics), such as ethacrynic acid and furosemide.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if
you are breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
During pregnancy, the product should be administered only when necessary and under
the direct supervision of a doctor.

Driving and operating machinery
There are no contraindications.

Genticol 3 mg/g ophthalmic ointment contains anhydrous lanolin
Lanolin can cause local skin reactions (e.g. contact dermatitis).

9. How to use Genticol

Use this medicine following the instructions of your doctor exactly.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 – 4 applications per day.
If the use of Genticol eye drops is also planned, a single
evening application is sufficient.

Use in children
In children under 3 years of age, Genticol should be administered only when actually
necessary and under the direct supervision of a doctor.

Instructions for use

• 4) Wash/disinfect your hands thoroughly.
• 5) Open the tube.
• 6) Press the tube until an adequate amount of product comes out, taking care not to touch the eye, eyelid or any other surface with the tip of the tube; this can avoid contamination.
• 7) Close the tube immediately after administration.

If you use more Genticol than you should
No cases of overdose have ever been reported with the use of Genticol.

If you forget to use Genticol
Do not use a double dose to make up for a missed dose.

If you stop using Genticol
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects
although not everybody gets them.
Genticol may cause mild and temporary eye irritation.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more
information on the safety of this medicine.

11. How to store Genticol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack
and on the tube after “Exp.”.
The expiry date refers to the last day of that month and to the product
intact, correctly stored.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

12. Package Contents and Other Information

What Genticol contains

• The active ingredient is gentamicin; 1 g of ointment contains 3 mg of gentamicin (as gentamicin sulfate).
• The other ingredients are: liquid paraffin, anhydrous lanolin, white petrolatum.

Description of the appearance of Genticol and package contents
Genticol ophthalmic ointment is presented as a semi-solid mass of light yellow color
within a 5g tube.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
OmniVision Italia S.r.l.
Via Montefeltro, 6
20156 Milano
Manufacturer:
S.I.F.I. S.p.A.
Via Ercole Patti, 36
95025 Aci S. Antonio (CT)